| CTRI Number |
CTRI/2025/07/090448 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Bone Powder and Natural Glue to Help Rebuild Lost Bone Around Teeth |
|
Scientific Title of Study
|
Clinical and radiogrphical evaluation of Novabone porous granules with Autologus Fibrin Glue (Sticky bone) in Treatment of furcation defect- A Prospective In Vivo Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riddhika kochar |
| Designation |
PG student |
| Affiliation |
Km shah dental college , sumandeep vidyapeeth university Vadodra |
| Address |
Room no 7, Department of Periodontology, KM Shah dental College and Hospital
Vadodara
GUJARAT
397160
India |
| Phone |
08975953131 |
| Fax |
|
| Email |
riddhikakochar23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor in Department of Periodontology |
| Affiliation |
Km shah dental college , sumandeep vidyapeeth university Vadodra |
| Address |
Room no- 7, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760
Vadodara
GUJARAT
391760
India |
| Phone |
09974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor in Department of Periodontology |
| Affiliation |
Km shah dental college , sumandeep vidyapeeth university Vadodra |
| Address |
Room no- 7, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760
Vadodara
GUJARAT
391760
India |
| Phone |
09974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM Shah dental College and Hospital, Sumandeep Vidyapeeth University |
|
|
Primary Sponsor
|
| Name |
Riddhika kochar |
| Address |
Room no- 7, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Riddhika kochar |
KM Shah Dental College and Hospital |
Room no 7, Department of Periodontology KM Shah dental college and Hospital, Sumandeep Vidyapeeth
Waghodia,Vadodara
Pincode - 391760
Vadodara
GUJARAT |
08975953131
riddhikakochar23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Novabone porous granules with Autologus Fibrin Glue (Sticky bone) |
The intervention in this study involves the use of Sticky Bone, which is a combination of:
Novabone Porous Granules (an alloplastic bone graft material)
Autologous Fibrin Glue (AFG) prepared from the patient’s own blood.
Novabone porous particles are synthetic, bioactive glass granules that offer excellent osteoconductive properties and provide superior structural support within the bony defect. These particles promote bone regeneration and are known for their biocompatibility and stability.
Autologous Fibrin Glue (AFG) acts as a biological scaffold, enhancing cell migration (especially fibroblasts and mesenchymal cells), promoting angiogenesis, and serving as a hemostatic agent. It also helps in binding the bone granules together, forming a cohesive, moldable mass known as Sticky Bone.
Sticky Bone, first described by Sohn et al. in 2010, is a growth factor-rich matrix that helps stabilize the graft within the defect site, prevents graft loss, and inhibits soft tissue ingrowth, ultimately facilitating better bone regeneration and healing. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with a radiolucency in the furcation area on IOPA with probing depth (PD) more than or equal to 5mm and horizontal PD more than or equal to 3mm.
2.Patients with Generalized Periodontitis Stage II & III1 with grade II, III furcation defect.
3.Dentition with minimum 20 natural teeth with periodontitis with furcation involvement in molars
4.Non-mobile teeth |
|
| ExclusionCriteria |
| Details |
1.Patients who were on antibiotic prophylaxis before the periodontal examination.
2.Patients with systemic disease.
3.Pregnant and Lactating women
4.Participant with habit of smoking bidi or cigarettes, chewing tobacco or betel nut.
5.Patient not giving consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Horizontal Clinical attachment loss (HCAL) |
Baseline, 3 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index (PI) |
Baseline, 3 month, 6 month |
| Vertical Clinical attachment loss (VCAL) |
Baseline, 3 month, 6 month |
| Pocket probing defect (PPD) |
Baseline, 3 month, 6 month |
| Radiological defect depth (RDD) |
Baseline and 6 months |
| Bone Fill% |
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective in vivo study evaluates the clinical and radiographic effectiveness of using Novabone porous granules combined with Autologous Fibrin Glue (commonly known as Sticky Bone) in the treatment of furcation defects. The aim is to assess improvements in periodontal parameters and bone fill, providing insights into the regenerative potential of this biomaterial combination in managing challenging periodontal defects. |